November 30, 2011: Two New Jersey Dietary Supplement Firms and Their Principals Sentenced for Criminal Contempt

Food and Drug Administration Office of Criminal Investigations

U.S. Department of Justice Press Release

For Immediate Release November 30, 2011

United States Attorney District of New Jersey

WASHINGTON – New Jersey-based dietary supplement companies Quality Formulation Laboratories Inc. (QFL) and American Sports Nutrition Inc. (ASN), as well as their owner, Mohamed S. Desoky, and managers, Ahmad Desoky Esq., and Omar Desoky, were sentenced today for multiple counts of criminal contempt of court for violating a consent decree entered by the U.S. District Court for the District of New Jersey on March 16, 2010, the Justice Department announced.

The defendants' businesses manufactured and distributed food products and supplements, including many varieties of protein powder mixes sold in health food stores, as well as other powder mixes and dietary supplements. The defendants' products were distributed under the ASN brand to locations throughout the United States.

U.S. District Court Chief Judge Garrett E. Brown Jr. sentenced Mohamed S. Desoky to a term of 40 months in prison, three years supervised release and a fine of $60,000; Ahmad Desoky Esq., to a term of 34 months in prison, three years supervised release and a fine of $12,000; and Omar Desoky to a term of 34 months in prison and three years supervised release. In addition, Judge Brown ordered QFL and ASN to pay criminal fines totaling $1 million, and placed them on probation for a period of three years. All defendants, the individuals and the corporations, were prohibited from doing business in the dietary supplement industry during their periods of supervised release or probation unless they first obtained consent of the U.S. Food and Drug Administration and the Court. Ahmad Desoky was barred from practicing law during his period of supervised release. In imposing sentence, the court commented that defendants' criminal contempt was unique in its persistence and scope.

The complaint in the civil case that led to the court order alleged that the defendants, which included Mohamed S. Desoky, QFL and ASN, adulterated food by manufacturing them without following the Food and Drug Administration's (FDA) regulations regarding current good manufacturing practice (CGMP) requirements.

The complaint alleged that the defendants caused misbranding of food because the food contained milk, a major food allergen, not declared on the product labels. The civil complaint went on to allege that defendants' failure to have adequate sanitizing and cleaning operations and follow their own procedures for manufacturing products on dedicated equipment may have led to food being contaminated with this major food allergen by virtue of "cross-contamination" or "cross-contact" in the manufacturing process.

The civil complaint also alleged that during an FDA inspection of the defendant's facility in January 2009, FDA investigators observed a dead rodent - cut in half - on a blender motor platform; a dead rodent, surrounded by rodent excreta pellets, in an area used to store near-finished product; and, on two occasions, a live rodent running through the blending room.

The consent decree that settled the civil action required that defendants shut down their manufacturing operation and not reopen there or elsewhere without first correcting these violations and getting FDA's approval to reopen. The criminal contempt charges alleged that Ahmad Desoky and Omar Desoky, with knowledge of the court's order, assisted their father, Mohamed S. Desoky, in violating the order, and thus were criminally liable for the violations even though they were not named as defendants in the original civil case.

"After the FDA found egregious sanitation and manufacturing problems at the defendants' facility, we obtained a court order requiring the defendants to clean up their act," said Tony West, Assistant Attorney General of the Civil Division of the Department of Justice. "Instead of complying with that order, the defendants thumbed their nose at it and continued distributing product. The court's appropriately stiff sentences in this case make clear the lesson: If you jeopardize the health and safety of the American people, we will hold you accountable."

The petition for criminal contempt charged all five defendants with violating the decree almost immediately upon its entry by setting up operations at a separate location in Congers, N.Y., to which they transported their employees and equipment. In addition, the petition alleged that the defendants violated the decree by failing to notify FDA of this relocation of their operations. On June 1, 2011, a jury found all five defendants guilty of these charges.

The petition also alleged that QFL, Mohamed S. Desoky, Ahmad Desoky and Omar Desoky continued receiving and manufacturing operations at their Paterson. N.J., facility despite the court's order. These defendan ts were found guilty of this charge as well.

Finally, the petition alleged that QFL, Mohamed S. Desoky, and Ahmad Desoky received and distributed product at their Paterson facility between September 2010 and January 2011, in violation of the court's order. The jury found these defendants guilty of this count.

Assistant Attorney General West thanked the FDA for the referral of the civil case and the diligent investigation of the ensuing violations of the court's order.

The prosecution of these defendants was handled by Department of Justice, Civil Division, Consumer Protection Branch Trial Attorneys David Sullivan and Patrick Runkle, and District of New Jersey Assistant U.S. Attorney Howard Wiener. The FDA Office of Chief Counsel Attorney Shannon Singleton supported the matter, which was investigated criminally by the FDA Office of Criminal Investigations, Jersey City Branch, and civilly by the FDA New Jersey District Office.